Site and Intervention Provider Eligibility Section
SPIRIT 2025 distinguishes eligibility for trial sites and for individuals who deliver the interventions from participant eligibility. Do not merge these criteria with participant inclusion/exclusion criteria; site and provider requirements answer a different methodological question and vary by intervention and setting.
A Site and Intervention Provider Eligibility section states the qualifications or conditions required of participating sites and, when relevant, the people who deliver the interventions.
Key details
Important caveats
Scope Boundary
Do not merge these criteria with participant inclusion/exclusion criteria; site and provider requirements answer a different methodological question and vary by intervention and setting.
Further guidance
Content
Describe site-level requirements and provider qualifications, training, experience, facilities, certification, or other criteria that materially affect intervention delivery.
Purpose
Clarify who or what is eligible to deliver the protocol and where it may be delivered.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- SPIRIT 2025 statement: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 reporting guideline for the minimum content of randomized-trial protocols, including amendments and protocol transparency.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.